Cape Cod lung cancer study embraced by patients

Cape Codders have responded positively to a call for clinical study participants in the quest to identify a blood test to detect lung cancer.

Cape Cod Hospital (CCH) has been working cooperatively with Freenome Holdings, Inc. in the California-based biomedical company’s clinical study since July of 2024, when the call went out for smokers and former smokers to play a part in this promising area of research. So many people have signed up for the project, CCH was a top enrolling site in the nation for the months of April and September, according to the principal investigator on the study for Cape Cod Healthcare (CCHC), medical oncologist Peter Ward, MD. CCH is one of six trial sites around the country to have enrolled the most patients, he said.

“It’s quite an honor,” added Elizabeth Sampson, senior oncology research program manager for CCHC, who, along with three clinical research coordinators, has been working closely with Dr. Ward. “It goes to show the hard work of the team.”

A Strong Screening Program

One of the reasons the Hyannis hospital was chosen by Freenome to be part of the study, was because of its robust lung cancer screening program, according to Sampson. As part of CCHC’s screening program, patients who are eligible, due to their smoking history, can receive a low-dose CT scan to screen for undetected lung cancer.

The American Cancer Society screening guidelines recommend that primary care or specialty care providers refer patients for low-dose CT screening who are 50-80 years old, if they currently smoke or formerly smoked cigarettes, and have a 20-pack year or more history of smoking. Pack years are gauged by the number of packs of cigarettes smoked per day times the number of years smoked. For example, someone who smoked one pack of cigarettes a day for 20 years, or two packs a day for 10 years (and either still smokes or has quit in the past 15 years) would qualify for screening.

To take part in the Freenome clinical study, eligible low-dose CT patients agree to a simple blood draw prior to their CT scan, which is sent to Freenome for its research. The blood test looks for the presence of the DNA of a cancerous tumor.

“Part of cancer care is clinical research, and a lot of the research is looking at ways to de-escalate treatment; give less treatment that is just as effective for survival,” said Sampson.

In addition to the blood test, trial participants are asked to fill out a questionnaire, and they agree to be followed for 24 months. Patients will never know the results of the blood test, nor will researchers at CCH. They have agreed to be part of the study in an effort to advance medical science and potentially help save lives in the future.

“There is a high degree of altruism on the part of patients who have enrolled in this,” said Dr. Ward. “It’s not like the typical clinical trial where there’s a drug that’s being tested and the sponsor we’re working with could give us those results and say, ‘yes, this drug worked out,’ or ‘no the drug didn’t work,’ or ‘these are the side effects,’ and they could share those with us.

“The data that’s being collected in (the Freenome study) is not something that we would act on or be able to explain to our patients in real time.”

Down the line, it’s possible Dr. Ward and the clinical trials team could see some results in a published paper that explains how the test was validated, and it would have probability and statistics that would help guide clinicians on how good the test was.

“To do a study like this, you have to have a number of (medical) centers that are doing this, and they have to do it at a certain pace,” he said. Most of the medical sites that are participating in the Freenome blood test study are community cancer centers, like CCHC, which Dr. Ward said was a good thing because “you get a slice of the general population.” Participating centers need to have a low-dose screening program set up, with primary care providers on board, as well as a clinical team that can help identify and approach potential trial participants, he added.

Participants Still Needed

Freenome is not alone in its pursuit of a blood test to detect lung cancer. According to Dr. Ward, other companies are also focused on the goal of bringing a test to market. The Freenome study is in the process of reaching its goal for enrolling trial participants, with study completion projected for 2027, he said.

As a result, enrollment in the trial is still open and Cape Cod participants are still welcome, he said.

Sampson and her team are spreading the word about the blood test to Cape Cod primary care and specialty care offices and elsewhere. Flyers are also posted in pulmonary clinics and the radiology department at CCH.

General and thoracic surgeon Jeffrey Spillane, MD, FACS and pulmonologist Michael Ayers, MD, FCCP follow up with patients in whom suspicious nodules are detected during the low-dose screening. For those patients, more in-depth diagnostic steps are then taken, said Sampson.

In addition to the blood test, participants agree to a 12- and 24-month follow-up phone call from a member of the CCH clinical trial team to go over any health updates they may have. There is no risk for the patient, since, following the blood test, they receive the low-dose CT screening anyway.

Even if a blood test is eventually brought to market to screen for lung cancer, it would not negate the need for follow-up CT in patients whose blood tests are positive for cancer, said Dr. Ward. It is similar to the in-home stool test, Cologuard, which detects cancer DNA and, if found, the patient would then need a colonoscopy.

If and when blood tests to detect various cancers are developed and made generally available, the blood test would likely be drawn at your annual physical, Dr. Ward said. If cancer DNA was detected, it would be followed up with some type of imaging study, depending on the area of the body you were testing.

“I wouldn’t say that mammograms and colonoscopies would go away, but they wouldn’t have to be used as frequently,” he said. Those whose screening blood test was negative for the presence of cancer would not need the follow-up study.

What it Means for CCH

Participation in the Freenome and other ongoing clinical trials has helped elevate CCH’s status in the clinical trial world, said Dr. Ward.

“Any community cancer center is somehow judged on their accruals (how many people participate). That was part of the reason we wanted to sign up for this,” he said. “Having a trial like this where there’s many patients who have to go through the (low-dose CT) screening, where we can approach and enroll a good fraction of those patients, it brings our accruals up a lot,”

The other clinical trials that CCH is involved with are looking at specific new medications for certain diseases. They are randomized controlled trials, and it’s harder to enroll patients because it’s for a more specific disease category. For example, the hospital team, with medical oncologist Edward Wyluda, DO as principal investigator, is currently involved in a trial for a drug for the treatment of HER2-positive breast cancer.

“We want to be able to open clinical trials in areas that will have a more direct impact on patients, like drugs that may not be FDA approved yet,” said Dr, Ward. “It’s potentially a way for some patients to receive new medications (some would receive a placebo). That’s kind of the goal of the research program, in my view, to be able to offer more therapeutics to patients that may not be available through the standard of care.”

Sampson said she is more enthusiastic than ever about the Freenome trial and the others being conducted at CCH, because Cape Cod patients who wish to participate don’t have to travel to Boston or elsewhere off Cape.

“Ultimately, we’re here for the patient, and if we can do clinical trials locally, what a benefit for our patients,” she said.